At Clinical Research Pivot, we offer comprehensive clinical research monitoring services delivered by highly qualified and experienced Clinical Research Associates (CRAs). Our CRAs are experts in ensuring that clinical trials adhere to Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols, while prioritizing patient safety and data integrity.
What Our Monitoring Services Include:
- Protocol Compliance: Our CRAs meticulously oversee that all clinical trial activities at investigative sites strictly follow the study protocol, ensuring patient safety and data reliability.
- Source Data Verification (SDV): We conduct detailed reviews of the data entered into Case Report Forms (CRFs), cross-referencing it with source documents to ensure accuracy and completeness.
- On-Site & Remote Monitoring: We offer both on-site and remote monitoring services to ensure continuous oversight, flexibility, and seamless communication with sites, even in challenging circumstances.
- Risk-Based Monitoring: Using advanced technology and risk-assessment models, our CRAs focus monitoring efforts on high-risk areas to improve efficiency and maintain trial quality.
- Adverse Event Reporting: We closely track and ensure timely reporting of adverse events and serious adverse events (SAEs), minimizing delays and safeguarding patient welfare.
- Investigational Product Accountability: Our CRAs ensure proper handling, storage, and accountability of investigational products, complying with study requirements and maintaining data integrity.
- Ongoing Site Communication and Management: Our CRAs maintain strong relationships with site personnel, providing training, answering queries, and ensuring that all team members are aligned with study requirements and timelines.
Why Choose Our Monitoring Services?
- Experienced CRAs: Our team is comprised of CRAs with 10+ years of experience across multiple therapeutic areas, including oncology, cardiology, neurology, and many more.
- Regulatory Expertise: Our CRAs are experts in FDA, IRB, and ICH-GCP regulations, ensuring your trial stays compliant with the latest industry standards.
- Tailored Approach: We customize our monitoring plans to fit the specific needs of your trial, offering risk-based monitoring strategies that improve efficiency and focus on critical data points.
With Clinical Research Pivot, you can trust that your clinical trial is being monitored by experienced professionals committed to maintaining the highest standards of quality, safety, and regulatory compliance.